Xanomeline/Trospium Chloride Capsule / Alzheimer Disease / Xanomeline Enteric Capsule · Phase 3 Trial

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active Phase 3 trial evaluating xanomeline/trospium chloride combinations (KarXT + KarX-EC) versus placebo for Alzheimer's-associated agitation. No efficacy or safety results are yet available in this registry record; the trial is currently recruiting.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimer Disease; age from 55 Years; to 90 Years. Intervention: KarXT + KarX-EC. Compared with: Placebo — Placebo Comparator. n = 426. 159 sites across 15 countries.

Key findings

Safety

Safety and efficacy outcomes not yet available; premature to assess clinical benefit.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 registry record with no reported results; the study is actively recruiting and outcome data are not yet posted.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14 (assessed at At Week 14)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationAlzheimer Disease; age from 55 Years; to 90 Years

Sample size426

InterventionKarXT + KarX-EC

ComparatorPlacebo — Placebo Comparator

Setting159 sites across 15 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size426

Primary outcome measureChange from baseline on Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14

Study phasePHASE 3

Primary timepointWeek 14

Caveats

No results are reported in this registry record; trial is actively recruiting.
Randomization method, blinding status, and allocation concealment not described in registry excerpt.
Safety and efficacy outcomes not yet available; premature to assess clinical benefit.
Effect sizes, confidence intervals, p-values, and secondary outcomes not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 interventional design with placebo control specified.

Directness

strong

Clinical outcome measure (CMAI-IPA) directly assesses agitation in target population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Blinding status, randomization method, and trial conduct details not stated in registry.

Sample adequacy

moderate

Planned enrollment 426 participants; adequacy depends on effect size assumption not disclosed.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07011732). This is a study registration, not published results. Lead sponsor: Bristol-Myers Squibb. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 426 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: DRUG: Xanomeline/Trospium Chloride Capsule; DRUG: Xanomeline Enteric Capsule; DRUG: Placebo. Primary outcome measures: Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14 , At Week 14. Brief summary: The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Xanomeline/Trospium Chloride CapsuleAlzheimer DiseaseXanomeline Enteric CapsuleNCT07011732Bristol-Myers Squibb